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EC number: 206-986-0 | CAS number: 407-41-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-03-07 to 2017-05-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- O-phosphoserine
- EC Number:
- 206-986-0
- EC Name:
- O-phosphoserine
- Cas Number:
- 407-41-0
- Molecular formula:
- C3H8NO6P
- IUPAC Name:
- O-phosphonoserine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- OTHER SPECIFICS: white powder
Method
- Target gene:
- his/trp
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, male Wistar rat pretreated with beta-Naphthoflavone/Phenobarbital
- Test concentrations with justification for top dose:
- The test material concentrations used were selected according to the EEC, OECD and Japanese guidelines for this test system.
A maximum concentration of 5000 µg/plate was selected, in order that initial treatments were performed up to the maximum recommended concentration according to current regulatory guidelines (OECD TG 471, 1997).
1st series: 5.0, 15.8, 50.0, 158, 500, 1580, 5000 µg/plate, 10% S9 mix
2nd series: 50.0, 158, 500, 1580, 5000 µg/plate, 20% S9 mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of vehicle: Comparing the standard solvents for this assay indicated that the test substance showed best solubility performance in ultra-pure water. Based on these preliminary data, ultra-pure water was selected as vehicle for the current experiment.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Dauromycin
- Remarks:
- 1.0 µg/plate, TA98, wihthout S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 2.0 µg/plate, TA100, TA1535, without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 50.0 µg/plate, TA1537, without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 2.0 µg/plate, E. coli, without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- 2.0, 5.0, 10.0 µg/plate, all strains, with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 - 3 days at 36 - 38 °C
SELECTION AGENT (mutation assays):
Commercially available Minimal-Glucose-Agar plates (Art. 146690, Charge 143118, Merck Life Science, 69214 Eppelheim, Germany) were used for all strains.
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- The assessment of test material-induced effects is dependent on the number of spontaneous re-vertants of each bacteria strain (solvent controls) and the increase in the number of revertants at the test material concentration which shows the highest number of colonies. The following criteria, based upon the historical controls of the laboratory and statistical considerations, are established (see "Any other information on materials and methods").
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 2: Summary 1st series
Metabolic activation |
Test Material |
Concentration [µg/plate] |
Revertants per plate (Mean± SD) |
||||
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
|||
Without S9 mix |
H2O |
|
37± 10 |
124± 10 |
24± 4 |
8± 3 |
33± 7 |
Test Substance |
5.0 |
36± 2 |
106± 10 |
23± 2 |
7± 1 |
37± 1 |
|
15.8 |
35± 3 |
115± 11 |
22± 7 |
6± 3 |
38± 6 |
||
50.0 |
29± 12 |
21± 4 |
22± 6 |
8± 2 |
44± 3 |
||
158 |
38± 3 |
117± 13 |
19± 10 |
7± 2 |
37± 13 |
||
500 |
29± 7 |
102± 11 |
26± 3 |
11± 7 |
41± 6 |
||
1580 |
31± 4 |
105± 6 |
21± 8 |
12± 6 |
34± 9 |
||
5000 |
26± 12 |
121± 6 |
22± 4 |
7± 1 |
|
||
DAUN |
1.0 |
186± 8 |
|
|
|
|
|
NaN3 |
2.0 |
|
1470± 72 |
819± 22 |
|
|
|
9-AA |
50.0 |
|
|
|
561± 221 |
|
|
NQO |
2.0 |
|
|
|
|
1566± 53 |
|
With S9 mix |
H2O |
|
44± 7 |
132± 8 |
22± 4 |
7± 1 |
35± 5 |
Test Substance |
5.0 |
40± 7 |
120± 19 |
25± 5 |
5± 4 |
37± 4 |
|
15.8 |
36± 1 |
135± 12 |
18± 2 |
7± 1 |
42± 3 |
||
50.0 |
39± 6 |
149± 14 |
22± 3 |
10± 4 |
49± 10 |
||
158 |
37± 2 |
127± 9 |
17± 3 |
10±4 |
41± 2 |
||
500 |
46± 5 |
118± 9 |
25± 5 |
11± 4 |
38± 5 |
||
1580 |
36± 4 |
132± 21 |
21± 4 |
12± 6 |
40± 12 |
||
5000 |
46± 11 |
130± 16 |
21± 9 |
10± 2 |
42± 2 |
||
2-AA |
2.0 |
741± 59 |
1014± 140 |
|
|
|
|
2-AA |
5.0 |
|
|
196± 31 |
442± 25 |
|
|
2-AA |
10.0 |
|
|
|
|
373± 64 |
NaN3, Sodium azide
2 -AA, 2-Aminoanthracane
9 -AA, 9-Aminoacridine
DAUN, Daunomycin
NQO, 4-Nitroquinoline-N-oxide
Table 3: Summary 2nd series
Metabolic activation |
Test Material |
Concentration [µg/plate] |
Revertants per plate (Mean± SD) |
||||
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
|||
Without S9 mix |
H2O |
|
40± 7 |
145± 15 |
35± 5 |
7± 3 |
34± 9 |
Test Substance |
50.0 |
47± 9 |
158± 12 |
37± 7 |
5± 1 |
28± 5 |
|
158 |
39± 6 |
164± 34 |
37± 11 |
7± 2 |
36± 8 |
||
500 |
30± 2 |
150± 16 |
34± 1 |
7± 3 |
34± 3 |
||
1580 |
40± 8 |
134± 14 |
30± 2 |
6± 1 |
35± 9 |
||
5000 |
45± 7 |
163± 27 |
31± 5 |
8± 2 |
42± 3 |
||
DAUN |
1.0 |
379± 89 |
|
|
|
|
|
NaN3 |
2.0 |
|
1731± 42 |
1048± 45 |
|
|
|
9-AA |
50.0 |
|
|
|
565± 109 |
|
|
NQO |
2.0 |
|
|
|
|
1960± 25 |
|
With S9 mix |
H2O |
|
58± 11 |
131± 14 |
24± 9 |
9± 3 |
40± 10 |
Test Substance |
50.0 |
51± 14 |
155± 18 |
28± 5 |
9± 1 |
43± 6 |
|
158 |
47± 12 |
141± 4 |
20± 6 |
8± 2 |
33± 4 |
||
500 |
57± 3 |
141± 4 |
29± 6 |
5± 2 |
40± 4 |
||
1580 |
55± 14 |
131± 13 |
27± 5 |
10± 4 |
36± 6 |
||
5000 |
42± 4 |
133± 5 |
20± 3 |
9± 2 |
38± 8 |
||
2-AA |
2.0 |
362± 13 |
598± 16 |
|
|
|
|
2-AA |
5.0 |
|
|
188± 24 |
126± 28 |
|
|
2-AA |
10.0 |
|
|
|
|
192± 4 |
NaN3, Sodium azide
2 -AA, 2-Aminoanthracane
9 -AA, 9-Aminoacridine
DAUN, Daunomycin
NQO, 4-Nitroquinoline-N-oxide
Applicant's summary and conclusion
- Conclusions:
- In an in vitro bacterial reverse mutation assay (Ames test) according to OECD Guideline 471 with and with out metabolic activation (S9 mix), the test substance showed no mutagenic potential.
- Executive summary:
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium test strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA according to OECD Guideline 471 (reference 7.6.1 -1). The plate incorporation test with and without addition of liver S9 mix from rats pretreated with beta-Naphthoflavone/Phenobarbital was used. In this study, two experimental series were performed. The S9 mix used contained 10% S9 in the 1st and 20% S9 in the 2nd series, respectively. Treatments of all test strains were performed using the test item prepared in ultra-pure water in the absence and in the presence of S9 mix, using final concentrations of 5.0, 15.8, 50.0, 158, 500, 1580, and 5000 µg/plate, plus vehicle and positive controls. Solvent and positive control treatments were included and valid for all strains. The mean numbers of revertant colonies all fell within acceptable ranges for solvent control treatments, and were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. Following treatment of all bacteria test strains with the test substance in the absence and presence of S9 mix, no relevant increases in revertant numbers were observed.Furthermore, it was assumed, that the anhydrate form has the same mutagenic potential and thus the result of the test item is also applicable.
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